Category Archives: Events

01Jun/17
webinar pic

Webinar Announced: How Connected Devices Improve Patient Outcomes

Designing and Manufacturing Devices that Excel in an Internet of Medical Things (IoMT) World

register

Daniel Matlis, President of Axendia and Jordan Reynolds, Senior Manager, Kalypso, will discuss how innovative companies should navigate the perilous intersection of FDA approval, quality manufacturing and support for superior patient outcomes during a live webinar at 1:30pm Eastern on June 20, 2017.

The device industry is changing rapidly — and with change you have winners and losers. Today’s winners are embracing connectivity and the quickly emerging internet of medical things (IoMT) movement.  They understand that the future is continuous glucose monitoring systems that connect to handheld meters, sensor-embedded hospital beds that proactively alert providers to problems, wearable mHealth devices which can send information to caregivers or a multitude of other remote patient monitoring technologies.

Getting these new products approved by the FDA is hard enough, making sure they connect properly with patients, physicians and healthcare centers is even harder.

Register today to learn how smart, connected devices are changing the device ecosystem in support of patient outcomes.

25Apr/17
Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.

05Apr/17
Europe Conf

CLOSED LOOP PRODUCT LIFECYCLE MANAGEMENT

By: Eric M. Luyer, Market Research Analyst and Daniel R. Matlis, President

What Does it Mean to Medical Device Manufacturers?

Digital Transformation was the key topic at the PTC European Forum, held November 15th in Stuttgart, Germany.  Part of the day was devoted to clarifying how the Internet of Things (IoT) and Augmented Reality (AR), in relation to digital transformation, benefit decision-making processes.

We are living in a time where it seems like everyone and everything is getting connected using technology concepts such as IoT.  At the same time, there is a strong focus on improving product quality and value.  However, the products or related services are getting more complex and the market requires product delivery be on request.

PTC Europe ImageIt is interesting to hear and learn how new concepts and technologies such as IoT and augmented reality (AR) can be used specifically in the medical device industry: to drive success with the ability to create, produce and market innovative and value driven products to market quickly.

Certainly, in a global market, proactive strategies are needed to support improved product quality and patient outcomes while supporting compliance with applicable regulatory requirements.

Continue reading

01Feb/17
FDA_small

Hear Directly from FDA: Driving a Culture of Quality for Devicemakers

Webinar Announcement

FDA and Industry Find Common Ground Driving a Culture of Quality

DATE: March 1, 2017
TIME: 1:30PM Eastern

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

CFQ_Webinar1

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Continue reading